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Polypoid Choroidal Vasculopathy (PCV)Phase 4NCT03244657

Phase IV Clinical Trial (STAR Study) Extension Study of Conbercept Ophthalmic Injection for Treatment of Polypoid Choroidal Vasculopathy

A Phase 4 study testing conbercept ophthalmic injection (0.5mg) in people with Polypoid Choroidal Vasculopathy (PCV), run by Chengdu Kanghong Biotech Co., Ltd. at 30 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To explore efficacy and safety of 0.5 mg conbercept ophthalmic injection for long-term treatment of polypoid choroidal vasculopathy (PCV) subjects. Read more about this study

Who is it for?
Ages 45 to 85 years
Conditions the study is for
Polypoid Choroidal Vasculopathy (PCV)
What is being tested?
conbercept ophthalmic injection (0.5mg)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
30 sitesChina
Study dates
25 Apr 2017to 28 Feb 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (1) Sign the informed consent and be willing to receive follow-up at the time specified in the trial; (2) A subject who has completed all visits specified by STAR study protocol and who is within 3 months after end of the last visit (the following subjects can be included: during STAR study, an investigator decided to discontinue treatment from point of view of safety, but the risk factor has disappeared or become stable).
  • Note: Use the determined eye of STAR study as the target eye.

Who cannot join

  • (1) A subject who actively withdrew from the study during STAR study; (2) The target eye or the body ever received other anti-VEGF drugs (such as Macugen, Lucentis, Avastin, Eylea, Zaltrap, etc.) from start of STAR study to before screening of this study.
  • In the target eye or the body, there is any following disease and condition: an investigator thinks that if the subject participates in this study, the disease and condition (such as: the target eye has history of vitrectomy; blood pressure control of a hypertension patient is not ideal [ after treatment of antihypertensive drugs, blood pressure is still ≥ 150/95 mmHg]; AIDS; malignant tumors; active hepatitis; renal failure; severe mental, neurological, cardiovascular, respiratory and other systemic diseases; ankylosing spondylitis; systemic lupus erythematosus; heart stent surgery; and the like) may cause the subject to be at relatively large risk; (4) A subject who ever had stroke, transient ischemic attack, myocardial infarction, or acute congestive heart failure and other cardiovascular events within 6 months before screening (5) A subject who participated in any drug (not including vitamins or minerals) clinical trial within 3 months (if the test drug has long half-life and 5 half-lives > 3 months, then 5 half-lives are taken) before screening;(6) Not take effective contraceptive measure; Note: The following conditions are not excluded. I. Amenorrhea for 12 months under natural condition; or, under natural condition, amenorrhea for 6 months, accompanied with follicle stimulating hormone level in serum > 40 mIU/ml; II. 6 weeks after bilateral oophorectomy with/without hysterectomy;
  • Use one or more of the following contraceptive methods:
  • Sterilization (male with bilateral vasoligation, vasectomy)
  • Hormone contraception (implantable type, patch type, oral administration type)
  • Intrauterine device, double-barrier method IV. Be able to take reliable contraceptive measure throughout the study and insist on it till 30 days after discontinuation of the investigational drug (unacceptable contraceptive methods include: regular abstinence, i.e., depending on calendar, ovulatory period, body temperature measurement method and post-ovulation period method; coitus interruptus for extracorporeal spermiation). (7) Pregnant (in this trial, pregnancy is defined as positive urine pregnancy test), lactating females (8) A subject whom an investigator thinks needs to be excluded.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

China30 sites, 30 recruiting
  • Beijing Hospital

    Beijin

    Dai Hong

    Not yet recruiting
  • The Chinese people's liberation army 474 hospital

    Beijin

    Xiao Yun

    Not yet recruiting
  • Beijing Tongren Hospital,Cmu

    Beijing

    Zhang feng

    Not yet recruiting
  • Chinese Pla General Hospital

    Beijing

    Li Chaohui

    Not yet recruiting
  • Peking Union Medical College Hospital

    Beijing

    Chen Youxin

    Not yet recruiting
  • Peking University First Hospital

    Beijing

    Yang Liu

    Not yet recruiting
  • Peking University People'S Hospital

    Beijing

    Li Xiaoxin

    Recruiting
  • PEKING UNIVERSITY Third HOSPITAL

    Beijing

    Dou Hongliang

    Not yet recruiting
  • Xiangya Hospital Central South University

    Changsha

    XU Huizuo

    Not yet recruiting
  • Hainan Eye Hospital of Zhongshan Ophthalmic Center, Sun Yat-sen University

    Hainan

    Cheng Wangling

    Not yet recruiting
  • Hebei Eye Hospital

    Hebei

    Zhang Minglian

    Not yet recruiting
  • The Second Hospital of Hebei Medical University

    Hebei

    Ma Jingxue

    Not yet recruiting
  • Henan Province People's Hospital

    Henan

    Fan Ke

    Not yet recruiting
  • The Second Hospital of Jilin University

    Jilin City

    Su Guanfang

    Not yet recruiting
  • Lanzhou University Second Hospital

    Lanzhou

    Zhang Wenfang

    Not yet recruiting
  • Affiliated Eye Hospital of Nanchang University

    Nanchang

    Yi Jinglin

    Not yet recruiting
  • The First Affiliated Hospital of Nanchang University

    Nanjing

    Zhou Qiong

    Not yet recruiting
  • The First Affiliated Hospital With Nanjing Medical University

    Nanjing

    Liu Qinghuai

    Not yet recruiting
  • Eye&Ent Hospital of Fudan University

    Shanghai

    Zhang Yongjin

    Not yet recruiting
  • Renji Hospital Shanghai Jiaotong University School of Medicine

    Shanghai

    Liu Lin

    Not yet recruiting
  • Shanghai General Hospital

    Shanghai

    Yu Suqin

    Not yet recruiting
  • Stu/Cuhk Joint Shantou International Eye Center

    Shantou

    Cheng Weiqi

    Not yet recruiting
  • Shanxi Eye Hospital

    Shanxi

    Jia Yading

    Not yet recruiting
  • Shenzhen Eye Hospital

    Shenzhen

    Cheng Qingshan

    Not yet recruiting
  • Tianjin Medical University Eye Hospital

    Tianjin

    Li Xiaorong

    Not yet recruiting
  • The Eye Hospital of Wmu Zhejiang Eye Hospital

    Wenzhou

    Liu Xiaoling

    Not yet recruiting
  • Renmin Hospital of Wuhan University

    Wuhan

    Xing Yiqiao

    Not yet recruiting
  • Xiamen Eye Centre of Xiamen University

    Xiamen

    Wu Guoji

    Not yet recruiting
  • Ningxia Peple'S Hospital

    Yinchuan

    Ha Shaoping

    Recruiting
  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Zhejiang

    Yao ke

    Not yet recruiting

Other trials in China

About this study

To explore efficacy and safety of 0.5 mg conbercept ophthalmic injection for long-term treatment of polypoid choroidal vasculopathy (PCV) subjects.

Being tested
conbercept ophthalmic injection (0.5mg)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • conbercept ophthalmic injection (0.5mg)Drug

    The target eye receives intravitreal injection of 0.5mg conbercept ophthalmic injection once every 12 weeks; if a subject meets "additional drug administration criteria" within 12 weeks between treatments, the subject can receive additional injection treatment

  • conbercept ophthalmic injection (0.5mg)Drug

    In principle, the first administration time of the target eye uses the time determined by the assessment at end of STAR study; later, based on "treatment-extension drug administration criteria", an investigator determines next visit time/treatment interval according to assessment result at each visit.When a subject's visit/treatment interval extends to 12 weeks, an additional safety visit can be arranged if an investigator considers that there is suspicious active lesion; if assessment result at the safety visit meets "additional drug administration criteria", additional injection treatment can be given.

Study groups in NCT03244657
Study groupRoleWhat they receive
Q12W groupExperimentalNot described
Receives: Drug: conbercept ophthalmic injection (0.5mg)
TAE groupExperimentalNot described
Receives: Drug: conbercept ophthalmic injection (0.5mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change of best corrected visual acuity (BCVA)

    Assess mean of change of best corrected visual acuity (BCVA) compared with baseline in the target eyes (using the same target eyes as STAR study) of subjects at end of the extension study;

    Measured: up to 40 week

  2. adverse events

    Assess incidence and severity of adverse events in subjects.

    Measured: up to 40 week

Secondary outcomes (4)
  1. mean of change of BCVA

    Assess mean of change of BCVA compared with that in STAR study baseline (before treatment) in the target eyes of subjects at end of the extension study

    Measured: up to 40 week

  2. change of central retinal thickness (CRT)

    Assess mean of change of central retinal thickness (CRT) compared with baseline in the target eyes of subjects at time of each visit till end of the extension study;

    Measured: up to 40 week

  3. mean of change of lesion's maximum retinal thickness (MRT)

    Assess mean of change of lesion's maximum retinal thickness (MRT), retinal pigment epithelium detachment's (PED) volume and thickness, polypoid lesion area, retinal hemorrhage area and other imaging indicators compared with baseline in the target eyes of subjects at end of the extension study;

    Measured: up to 40 week

  4. average number of times of drug administration

    Assess average number of times of drug administration in two groups of subjects during the extension treatment;

    Measured: up to 40 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2017
  2. Study start25 Apr 2017
  3. Primary completion31 Oct 2019 (estimated)
  4. Study completion28 Feb 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03244657
Sponsor's protocol ID
KH902-STE-CRP-1.2
Status last verified
Jul 2017
First submitted
7 Aug 2017
Last updated
9 Aug 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing conbercept ophthalmic injection (0.5mg) in people with Polypoid Choroidal Vasculopathy (PCV), run by Chengdu Kanghong Biotech Co., Ltd. at 30 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Li xiaoxing (+86-13801153661, dr_lixiaoxin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change of best corrected visual acuity (BCVA) (time frame: up to 40 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.

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